Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu
Pharmaceutical Co., Inc., today announced commencement of a Phase 2
study of a d-Amphetamine Transdermal System (d-ATS) for the treatment of
Attention Deficit Hyperactivity Disorder (ADHD) in children and
adolescents. Currently, there is no approved amphetamine-based
transdermal treatment option available for ADHD.
The Phase 2 study is a randomized, double-blind, placebo-controlled,
crossover study to evaluate the safety and efficacy of d-ATS compared to
placebo in subjects between 6 and 17 years of age. The study is expected
to enroll approximately 90 subjects at up to 5 study sites and is
scheduled to conclude in the second quarter of 2013. Additional
information on the Phase 2 study will be made available on
ClinicalTrials.gov.